MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CONTROL UNIT DYONICS 25; ARTHROSCOPE

Model Number 7211010

Device Problem Image Display Error/Artifact (1304)

Patient Problem No Patient Involvement (2645)

Event Date 08/06/2020

Event Type  malfunction  

Event Description

It was reported that, the "dyonics 25 control unit" had issues while inserting a new cassette.The unit displayed error message "cassette insertion/pressure error".After this, when tried to solve the issue, it seemed the sensor of insertion was damaged.No case reported; therefore, there was no patient involvement.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The reported device, intended for use in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.There was a relationship found between the returned device and the reported incident.An analysis of the customer provided images found that a cassette insertion error was displayed onscreen and a exposed pressure port from the device.The complaint was confirmed and the root cause was associated with mechanical component failure.Factors, unrelated to the manufacturing and design of the device which could have contributed to the reported event, include pressure transducer malfunction or the latch keeper wear.A review of the device history records could not be completed since the provided product identification information did not match any known release of this part.A complaint history review found concluded this was a repeat issue.

• Brand Name: CONTROL UNIT DYONICS 25
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 10470018
• MDR Text Key: 204900596
• Report Number: 1643264-2020-01010
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 03596010543554
• UDI-Public: 03596010543554
• Combination Product (y/n): N
• PMA/PMN Number: K171794
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7211010
• Device Catalogue Number: 7211010
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1